Trial Outcomes & Findings for A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma (NCT NCT01199289)
NCT ID: NCT01199289
Last Updated: 2021-11-26
Results Overview
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
315 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-11-26
Participant Flow
This study was conducted at 61 centers in Austria, Belgium, Canada, Finland, Hungary, Netherlands, Poland, Russia, South Korea, and the United States; 47 of these sites enrolled participants from 04 October 2010 to 21 December 2011. 315 participants were enrolled, but 10 participants from 1 site were excluded from all analyses due to major issues of Good Clinical Practice (GCP) compliance and are not included in the participant flow.
A washout period for specific asthma medications was conducted after informed consent and prior to run-in period. After completing screening and meeting all eligibility criteria, all eligible participants underwent run-in visits for 4 weeks prior to randomization.
Participant milestones
| Measure |
Placebo
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
75
|
76
|
77
|
|
Overall Study
Participants Who Received Study Treatment
|
76
|
74
|
76
|
76
|
|
Overall Study
COMPLETED
|
68
|
68
|
71
|
65
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
5
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Overall Study
Ineligibility determined
|
2
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Overall Study
Noncompliance
|
1
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
4
|
|
Overall Study
Full consent withdrawn
|
2
|
2
|
2
|
3
|
|
Overall Study
Administrative decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol-specified criteria
|
3
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=76 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.8 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
43.6 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
46.0 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
46.5 Years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
45.7 Years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
282 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=73 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=75 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=74 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
|
-0.427 Score on a scale
Standard Deviation 0.784
|
-0.521 Score on a scale
Standard Deviation 0.796
|
-0.512 Score on a scale
Standard Deviation 0.728
|
-0.556 Score on a scale
Standard Deviation 0.810
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=73 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=75 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=74 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Pre-Bronchodilator
|
0.075 Liters (L)
Standard Deviation 0.323
|
0.035 Liters (L)
Standard Deviation 0.307
|
0.066 Liters (L)
Standard Deviation 0.367
|
0.058 Liters (L)
Standard Deviation 0.348
|
|
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Post-Bronchodilator
|
-0.052 Liters (L)
Standard Deviation 0.275
|
-0.019 Liters (L)
Standard Deviation 0.259
|
0.016 Liters (L)
Standard Deviation 0.227
|
-0.032 Liters (L)
Standard Deviation 0.285
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=75 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
AM
|
4.26 Litres/minute
Standard Deviation 39.220
|
-14.09 Litres/minute
Standard Deviation 46.708
|
-4.53 Litres/minute
Standard Deviation 46.468
|
-1.95 Litres/minute
Standard Deviation 44.624
|
|
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
PM
|
-0.22 Litres/minute
Standard Deviation 37.807
|
-11.56 Litres/minute
Standard Deviation 40.277
|
-9.16 Litres/minute
Standard Deviation 45.080
|
-7.96 Litres/minute
Standard Deviation 37.984
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.
Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=75 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
|
-0.630 Days
Standard Deviation 2.842
|
-0.187 Days
Standard Deviation 2.971
|
-0.727 Days
Standard Deviation 2.941
|
-0.798 Days
Standard Deviation 4.293
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.
Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation. Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21). Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=75 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Change From Baseline in Daily Asthma Symptom Score to Week 12
|
-1.531 Score on a scale
Standard Deviation 3.674
|
-1.816 Score on a scale
Standard Deviation 3.250
|
-1.629 Score on a scale
Standard Deviation 2.620
|
-1.607 Score on a scale
Standard Deviation 3.238
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations, and had non-missing baseline and post-baseline data.
The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993). Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score = mean of the responses to the 32 questions. Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=65 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=69 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=63 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
|
0.626 Score on a scale
Standard Deviation 0.901
|
0.596 Score on a scale
Standard Deviation 0.979
|
0.537 Score on a scale
Standard Deviation 0.710
|
0.587 Score on a scale
Standard Deviation 0.866
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least 1 dose of study treatment who were not excluded due to GCP violations
Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use. The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks).
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=76 Participants
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Proportion of Asthma Symptom-free Days
With use of SABA
|
0.230 Ratio
Standard Deviation 0.299
|
0.167 Ratio
Standard Deviation 0.263
|
0.198 Ratio
Standard Deviation 0.293
|
0.166 Ratio
Standard Deviation 0.267
|
|
Proportion of Asthma Symptom-free Days
Without use of SABA
|
0.201 Ratio
Standard Deviation 0.294
|
0.123 Ratio
Standard Deviation 0.241
|
0.181 Ratio
Standard Deviation 0.286
|
0.146 Ratio
Standard Deviation 0.256
|
SECONDARY outcome
Timeframe: Week 8 (days 60 and 64), and pre-dose on Week 10Population: The pharmacokinetic (PK) analyses set: all participants who received at least one dose of AMG 827 and who had at least 1 PK concentration measurement.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=35 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=29 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
|
3.1 Days
Interval 0.0 to 8.0
|
3.1 Days
Interval 0.0 to 9.1
|
3.9 Days
Interval 1.9 to 13.0
|
—
|
SECONDARY outcome
Timeframe: Week 8 (days 60 and 64), and pre-dose on Week 10Population: The pharmacokinetic (PK) analyses set: all participants who received at least one dose of AMG 827 and who had at least 1 PK concentration measurement.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=35 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=29 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
|
8.11 µg/mL
Standard Deviation 6.91
|
16.6 µg/mL
Standard Deviation 12.4
|
29.4 µg/mL
Standard Deviation 17.5
|
—
|
SECONDARY outcome
Timeframe: Week 8 (days 60 and 64), and pre-dose on Week 10Population: The pharmacokinetic (PK) analyses set: all participants who received at least one dose of AMG 827 and who had at least 1 PK concentration measurement.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=35 Participants
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=29 Participants
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
|
68.3 µg*day/mL
Standard Deviation 74.3
|
171 µg*day/mL
Standard Deviation 150
|
313 µg*day/mL
Standard Deviation 196
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
AMG 827 140 mg
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
AMG 827 210 mg
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
AMG 827 280 mg
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=76 participants at risk
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 participants at risk
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 participants at risk
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=76 participants at risk
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.4%
1/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.4%
1/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.3%
1/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.4%
1/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.3%
1/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Degeneration of uterine leiomyoma
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.4%
1/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Nervous system disorders
Sciatica
|
1.3%
1/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.3%
1/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
Other adverse events
| Measure |
Placebo
n=76 participants at risk
Participants received the matching placebo administered as a subcutaneous (SC) injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 140 mg
n=74 participants at risk
Participants received AMG 827 140 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 210 mg
n=76 participants at risk
Participants received AMG 872 210 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
AMG 827 280 mg
n=76 participants at risk
Participants received AMG 827 280 mg administered as a SC injection at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
2.6%
2/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
6.8%
5/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
9.2%
7/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
9.2%
7/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
5/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
6.8%
5/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
3.9%
3/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
3.9%
3/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.4%
1/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
5.3%
4/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
3.9%
3/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Infections and infestations
Sinusitis
|
5.3%
4/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
2.7%
2/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
5.3%
4/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
0.00%
0/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
6/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
10.8%
8/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
5.3%
4/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
10.5%
8/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
14.5%
11/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
24.3%
18/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
19.7%
15/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
18.4%
14/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
1/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
2.7%
2/74 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
1.3%
1/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
5.3%
4/76 • Day 1 to Week 16
All-cause mortality is reported for all participants randomized in the study that were not excluded from analysis due to GCP violations. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug that were not excluded from analysis due to GCP violations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER